Clinical Trail

Aim of the Study:

To assess the efficacy and safety of a Shavari Bar® on increasing the breast milk output in post-partum women.

Objectives:

Evaluate the efficacy of a formulation Shavari Bar® vs. control/ Placebo on increasing the breast milk output in post-partum women

Evaluate the safety of a formulation Shavari Bar® vs. control/Placebo on increasing the breast milk output in post-partum women

Study setting:

Dept. of Obstetrics & Gynecology, D Y Patil Hospital, Nerul, Navi Mumbai 400 706, Maharashtra, India

N M Medical Center

Methods: A prospective, randomized, parallel-group, double-blind, placebo-controlled study was conducted at 2 centers in women with gestational age 37 weeks or more who intended to breastfeed. An EC approval was obtained. The patients were randomized in two groups: Group A: Placebo and Group B: Shavari Bar®. Observations were noted on day 3-4 and Day 5-7. Parameters observed were time to noticeable breast fullness and milk volume measurements. Milk volume was measured after the expression of breast milk from both breasts using a standard breast pump. Milk volume was measured 72 hours after delivery or after the patient had at least consumed 4 bars whichever was later.

Results: Hundred and four patients were assessed for the study, 78 patients were randomized and completed the study. Of the 78 patients, 61 had undergone a lower (uterine) segment Caesarean section (LSCS) and 17 had a normal delivery. Demography and baseline data of patients enrolled were similar in both groups. There was a statistical difference in total milk volume between the two groups (p< 0.008). The time to breast fullness was 38.09 hrs and 30.49 hrs respectively in the placebo Vs treatment arm and milk volume was 49.69 ml and 64.74 ml respectively in the placebo Vs treatment arm. In the LSCS group, time to breast fullness was 40.65 hrs and 32.2 hrs (p 0.032) and similarly, the milk volume was 52.35 ml and 66.67 ml (p 0.029) respectively in the placebo vs. treatment groups.

In the FTND group time to breast fullness was 28.19 hrs and 24.78 hrs (p 0.475) and milk volume was 39.38 ml and 58.33 ml (p 0.084) respectively in the placebo vs treatment groups.

No adverse events were noted in either of the groups. Global assessment of the Satisfaction of mothers for lactation, the well-being of the child, taste and ease of use was better in the treatment arm than in the placebo arm.

Time to breast fullness and milk volume extracted after 72 hrs.